Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Overview
- Phase
- Phase 4
- Intervention
- Lidocaine 1% Injectable Solution
- Conditions
- Chronic Shoulder Pain
- Sponsor
- University of Miami
- Locations
- 1
- Primary Endpoint
- Number of participants at each Global Satisfaction Rating (GSR)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of using suprascapular nerve block for individuals with chronic spinal cord injury who have chronic shoulder pain.
Investigators
Timothy Tiu
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Male or female, 18-70 years of age, inclusive. 2 Neurological impairment secondary to SCI that occurred at least twelve (12) months prior to the Screening Visit; neurological level of injury between C6 and L5, inclusive.
- •Non-ambulatory, except for exercise or therapy purposes.
- •Uses a manual wheelchair. 5 History of chronic shoulder pain for ≥6 months that has been unresponsive to conservative treatment (e.g. physical therapy, pharmacological agents), and is rated as ≥4 out of 10 on an 11-point Numeric Rating Scale (NRS) (0 = "no pain"; 10 = "most intense pain imaginable") for average shoulder pain intensity during the week leading up to the Screening Visit.
- •Able and willing to comply with the protocol.
- •Able to give voluntary informed consent prior to the performance of any study-specific procedures.
Exclusion Criteria
- •Contra-indications to the procedure (e.g. infection, coagulopathy)
- •History of active cancer within 5 years
- •Adhesive capsulitis
- •Prior history of regenerative medicine intervention
- •Glucocorticoid injection within the past four weeks
- •Any medical condition, including psychiatric illness, which would interfere with the interpretation of the study results or the conduct of the study
Arms & Interventions
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Intervention: Lidocaine 1% Injectable Solution
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Intervention: Triamcinolone Injection
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Intervention: Suprascapular Nerve Block
Outcomes
Primary Outcomes
Number of participants at each Global Satisfaction Rating (GSR)
Time Frame: 1 month post procedure
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Number of participants reporting treatment related adverse events
Time Frame: Up to 12 months
As per treating physician evaluation of participant adverse events related to the intervention
Secondary Outcomes
- Number of participants at each Global Satisfaction Rating(Up to 12 months post procedure)
- Change in NRS scores(Baseline, 12 months)
- Change in DASH Questionnaire scores(Baseline, 12 months)
- Change in BPI-I scores(Baseline, 12 months)